Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris

Phase 2

• Conditions: Acne Vulgaris
• Interventions: Drug: VB-1953 - 2%; Drug: VB-1953 - 0% (Vehicle)

• Registration Number: NCT03900676
• Lead Sponsor: Vyome Therapeutics Inc.

Brief Summary

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,

Detailed Description

This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:

Study Timeline

• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Study Start: 2019-04-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01
• Primary Completion: 2019-11
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Males or non-pregnant females 9 to 45 years of age (inclusive) at the time of consent/assent.
• Have a clinical diagnosis of moderate to severe (Grade 3 or 4) facial acne vulgaris, as determined by the Investigator's Global Assessment (IGA).
• Have 20 to 50 inflammatory lesions (papules, pustules) on the face.
• Have 20 to 60 non-inflammatory lesions on the face.

Exclusion Criteria

• Has more than two (2) facial nodulocystic lesions.
• Female subject is pregnant, lactating, or is planning to become pregnant during the study.
• Has active nodulocystic acne or acne conglobata, acne fulminans, or other forms of acne (e.g., acne mechanica). In the opinion of the Investigator, the subject has a skin pathology or other medical condition that is clinically significant (e.g., obesity) and will preclude participation in the study.
• Has presence of any skin condition on the face (e.g., rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acnetiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) in the opinion of the Investigator that could interfere with the diagnosis or assessment of acne vulgaris or evaluation of the investigational product (IP) or requires the use of interfering topical or systemic therapy.
• Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VB-1953 topical gel - 2% BID	VB-1953 - 2%	VB-1953 topical gel - 2% BID
VB-1953 topical gel- 0% (Vehicle) QD	VB-1953 - 0% (Vehicle)	VB-1953 topical gel- 0% (Vehicle) QD
VB-1953 Vehicle	VB-1953 - 0% (Vehicle)	VB-1953 topical gel- 0% (Vehicle) BID
VB-1953 topical gel - 2% QD	VB-1953 - 2%	VB-1953 topical gel - 2% QD

Primary Outcome Measures

Name	Time	Method
Inflammatory lesion counts	12 weeks	Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.

Secondary Outcome Measures

Name	Time	Method
Investigator's Global Assessment of Inflammatory Acne (IGA) score	12 weeks	Proportion of subjects achieving success at Week 12, with success defined as Investigator's Global Assessment of Inflammatory Acne (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from Baseline.
Percent change in inflammatory lesion counts	12 weeks	Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12

Trial Locations

Locations (2)

Vyome Therapeutics Inc; 🇺🇸 Miami, Florida, United States

Vyome Therapeutics Inc.; 🇺🇸 El Paso, Texas, United States